On 23 April, Swissmedic announced that they will be conducting a focus campaign of the requirements for post-market surveillance (PMS) of higher-risk medical devices. The announcement addresses Swiss manufacturers and Swiss authorised representative.
Swissmedic inspections of upper-class medical devices
Swissmedic will randomly select a specific number of Class IIa, IIb, and III devices placed on the market in Switzerland. In particular, the authority will request post-market surveillance documentation for these devices. The requests will arrive to Swiss manufacturers or the Swiss authorised representative in case of non-Swiss manufacturers.
PMS requirements in Switzerland
Manufacturers of medical devices placed on the Swiss market have to:
- establish a post-market surveillance system to collect data on their devices (Art. 56 MedDO),
- outline their activities in post-market surveillance plans (Art. 58 MedDO), and
- periodically document the results of their analyses in safety reports based on their plan (Art. 60-61 MedDO).
For any questions on how to prepare your PMS documentation, contact us here.
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